FDA Approves Pirtobrutinib for Untreated CLL and SLL

The FDA has approved pirtobrutinib, sold as Jaypirca by Eli Lilly, for adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma who do not carry the 17p chromosomal deletion, according to an FDA announcement.

This is a full approval, not an advisory recommendation, and it follows results from BRUIN CLL 313, a randomized, open label trial comparing pirtobrutinib against bendamustine plus a rituximab product in 282 patients. With a median follow up near 28 months, median progression free survival was not yet reached in the pirtobrutinib group, compared to 33.5 months in the chemotherapy arm, a difference the agency called statistically significant. Overall survival data remained immature, with few deaths recorded in either group so far.

Common side effects included upper respiratory infections, rash, and COVID 19, along with drops in neutrophil counts. Serious adverse reactions occurred in 28 percent of treated patients, and prescribing information carries warnings for infection risk, bleeding, low blood cell counts, heart rhythm problems, secondary cancers, liver toxicity, and fetal harm. The approved dose is 200 mg taken orally once daily until progression or unacceptable toxicity, a detail relevant only to prescribers managing this specific indication.

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